Johnson & Johnson Careers
Deliver Quality Assurance Associate
Requisition ID: 9187190704
This position supports the Quality and Regulatory Compliance function for Deliver Canada on behalf of Johnson & Johnson Medical Products, Janssen, and J&J Vision Care. As such, this position coordinates closely with the Deliver Operations teams, Deliver North America Quality and Compliance, Marketing Company Quality and Global Quality & Compliance groups to support the Deliver Quality and Compliance organization in Canada. Specifically, this position, coordinates and implements quality compliance programs related to the storage, handling and distribution of a broad portfolio of products including devices, drugs, narcotics, cosmetics and biologic products.
It supports the Deliver Canada organization with external and internal regulatory audits such as Health Canada and J&J JJRC. Takes direction from Deliver Leadership to execute the Quality Strategic Objectives and implements the overall company strategy. Will support and influence to represent quality with action and decisions involving audits, escalations, field actions or other significant quality events.
Assures compliance to appropriate processes, controls, training and qualifications followed to ensure a sound compliance profile for Deliver Canada in support of current and future business needs. Drives processes and systems to ensure that appropriate interfaces are in place end-to-end with Supply Chain and the Marketing Companies to which Deliver provides services.
- Implements and executes the quality system to ensure adherence to Good Manufacturing/Distribution Practices
- Writes and revises standard operating procedures and change controls
- Assists in conducting Gap Assessments of current SDC SOPs against JNJ standards
- Liaise between Franchise/Business Quality and SDC for quality and compliance issues.Oversees the execution of holds and recalls initiated by J&J Partner Companies
- Notify J&J Partner Companies on issues related to products requiring disposition
- Provide Quality support for the process of product destruction/return to ensure compliance and disposition of product where applicable.
- Liaise between Partner Companies and suppliers to ensure documentation management systems are current and meet all GMP/corporate/technical requirements
- Ensures GMP and GDP compliance for the distribution operations. This also includes participating in internal and external audits, assisting in maintenance of audit records and documenting follow-up from audits.
- Assist in the monitoring of Quality performance on DELIVER 3rd Party Logistics provider via supplier audits and day to day oversight.
- Ensures investigations and documentation of quality issues so that they are addressed and resolved in a timely manner.
- Works with inter-disciplinary teams across organizations to investigate, resolve and prevent quality issues.
- Assist in the preparation and monitoring of Quality Metrics and Key Performance Indicators.
- Assist in resolving issues with SAP system and working closely with Master Data Team to ensure accuracy of product information.
- Supports Quality Management reviews including J&J Operations, Supplier Quality and J&J partners.
- Overall monitoring of pest control, facility maintenance/validation and equipment calibration and resolution of any issues.
- Review BQ specifications for product relabeling/ rework and inspection activities and prepare work instructions for DC execution as required
- Owns the day to day oversight of the temperature monitoring processes in the DC (Distribution Center) and communication of alarm issues to Partner Companies
- Assist training deployment for J&J staff and 3PLs
- Supports DELIVER Quality on Commercial launch and New Business Development initiatives.
- Support quality aspects on projects, acquisitions and divestitures.
- Acts as back up to DELIVER QA Specialists as appropriate
- BSc or equivalent in Life Sciences or related field is required
- 2+ years’ experience working in a regulated environment
- Experience in a distribution or manufacturing setting
- Device or Pharmaceutical experience an asset
- Post graduate diploma in Quality and Reg Affairs, an asset
- Experience in Quality Systems, Corrective and Preventive Action/ Non-conformance systems, Good Manufacturing Practices/ Good Distribution Practices an asset.
- Process Excellence / Lean / TQM experience an asset.
- Attention to detail, sense of urgency, results and performance driven – works independently with minimum supervision
- Collaboration and partnership including cross-functional teams, negotiates and resolves conflicts effectively
- Ability to influence multiple stakeholders
- Exemplary communication skills including written and verbal
- Strong sense of integrity
- Good understanding of operations processes
- Strong technical writing skills
- Ability to apply risk management philosophy to business processes, decisions and data
Johnson & Johnson Inc. (7695)